Customized protective devices and systems and methods for producing the same

ABSTRACT

A clavicle protective device may include a contoured member configured to cover at least a portion of the clavicle. The contoured member may have an inner surface configured to face the at least a portion of the clavicle and an outer surface configured to face away from the at least a portion of the clavicle. The contoured member may include a first contact portion, a second contact portion, and a bridge portion positioned between the first contact portion and the second contact portion. The first contact portion may be configured to contact the subject&#39;s body above the clavicle. The second contact portion may be configured to contact the subject&#39;s body below the clavicle. The bridge portion may be configured to be spaced apart from the subject&#39;s body when the first contact portion and the second contact portion contact the subject&#39;s body.

CROSS REFERENCE TO RELATED APPLICATIONS

This application:

-   -   claims the benefit of and priority to U.S. Patent Application        No. 62/907,719, filed Sep. 29, 2019, entitled “CUSTOMIZED        PROTECTIVE DEVICES AND SYSTEMS AND METHODS FOR CREATING        CUSTOMIZED PROTECTIVE DEVICES”;    -   is a continuation-in-part application of the following patent        applications:        -   U.S. patent application Ser. No. 29/748,100, filed Aug. 27,            2020, entitled “AC JOINT PAD”; and        -   U.S. patent application Ser. No. 29/707,563, filed Sep. 29,            2019, entitled “CLAVICLE BRACE”; and incorporates each of            the above herein by reference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to protective devices wearableby a subject and more particularly to protective devices customized forwear by a particular subject to protect a portion of the subject's bodyfrom injury as well as related systems and methods for creatingcustomized protective devices.

BACKGROUND

Protective devices often may be worn by a subject (i.e., a person)desiring to protect a particular portion of the subject's body, forexample, during participation in athletic competition, militaryoperations, or even daily activities. Example protective devices mayinclude pads, braces, splints, supports, guards, shields, and othersimilar structural devices configured for covering or otherwisesupporting a desired body portion. In some instances, protective devicesmay be used with respect to an uninjured body portion to prevent orinhibit injury thereof. In other instances, protective devices may beused with respect to an injured or previously injured body portion toprevent or inhibit further injury or re-injury of the body portion andpromote desired healing. Providing protection for the intended bodyportion typically may be the primary goal in wearing a protectivedevice, which may be achieved by constructing the device from suitablematerials and to have a shape and size necessary to fit along andappropriately cover or support the intended body portion. However,additional goals often may include allowing the subject to maintain anormal range of motion while wearing the protective device and avoidingor minimizing any discomfort caused by wearing the device.

Various types of protective devices have been developed and used fordifferent purposes in protecting particular body portions. Mostcommonly, standard off-the-shelf protective devices may be used bysubjects seeking an affordable and readily-available device. Althoughstandard protective devices may be available in different sizes or sizeranges, such devices often may present certain limitations including,for example, improper fit, inadequate coverage, limited range of motion,and/or discomfort for a particular subject wearing the device. In someinstances, a customized protective device may be created for aparticular subject, thereby avoiding at least some of the limitationsassociated with standard devices. One technique for creating acustomized protective device is hand molding of a thermoplasticsubstrate to cover an intended body portion, which is a practice widelyused in collegiate and professional athletics. This technique, however,still may present certain shortcomings including, for example,constraints associated with the material, thickness, and geometry of thethermoplastic substrate as well as the experience and skill of theperson molding the protective device. Thus, hand-molded protectivedevices may not be able to simultaneously achieve the desired goals ofprotection, mobility, and comfort. Another technique for creating acustomized protective device involves casting a plaster mold around theintended body portion, and then forming the device based on a negativeof the plaster mold in a process similar to injection molding. Althoughthis technique may allow for greater variation in material, thickness,and geometry of the protective device as compared to hand-moldeddevices, the plaster-molding approach generally may be time-consumingand costly, particularly when multiple iterations are required toachieve a device that provides the protection, mobility, and comfortdesired by the intended subject.

A need therefore exists for improved customized protective devices forprotecting a portion of a subject's body from injury as well as relatedsystems and methods for creating customized protective devices.

BRIEF SUMMARY OF THE DISCLOSURE

In various embodiments, the present disclosure provides customizedprotective devices for protecting a portion of a subject's body frominjury as well as related systems and methods for creating customizedprotective devices. In one aspect, a clavicle protective device forprotecting a clavicle of a subject is provided. In one embodiment, theclavicle protective device may include a contoured member configured tocover at least a portion of the clavicle. The contoured member may havean inner surface configured to face the at least a portion of theclavicle and an outer surface configured to face away from the at leasta portion of the clavicle. In at least one embodiment, the inner surfacesubstantially conforms to the at least a portion of the clavicle. Thecontoured member may include a first contact portion, a second contactportion, and a bridge portion positioned between the first contactportion and the second contact portion. The first contact portion may beconfigured to contact the subject's body above the clavicle. The secondcontact portion may be configured to contact the subject's body belowthe clavicle. The bridge portion may be configured to be spaced apartfrom the subject's body when the first contact portion and the secondcontact portion contact the subject's body.

In some embodiments, the first contact portion and the second contactportion may be spaced apart from one another by the bridge portion. Insome embodiments, the bridge portion may be configured to extend overand be spaced apart from the at least a portion of the clavicle when thefirst contact portion and the second contact portion contact thesubject's body. In some embodiments, the contoured member may have anouter profile surrounding each of the inner surface and the outersurface, and the bridge portion may extend from a first location at afirst side of the outer profile to a second location at a second side ofthe outer profile. In some embodiments, the first side and the secondside may be positioned opposite one another. In some embodiments, thebridge portion may have a length in a first direction extending from thefirst location to the second location and a width in a second directiontransverse to the first direction, with the length being greater thanthe width.

In some embodiments, the bridge portion may include a channel extendingalong the inner surface. In some embodiments, the channel may have acurved profile along at least a portion of the bridge portion. In someembodiments, a curvature of the curved profile may vary along the atleast a portion of the bridge portion. In some embodiments, the channelmay have a U-shaped profile along at least a portion of the bridgeportion. In some embodiments, the bridge portion may include a ridgeextending along the outer surface. In some embodiments, the ridge mayhave a curved profile along at least a portion of the bridge portion. Insome embodiments, the ridge may have a U-shaped profile along at least aportion of the bridge portion. In some embodiments, the contoured membermay be formed of a material having an Izod impact strength that is equalto or greater than 90 J/m. In some embodiments, the material may have aflexural modulus that is equal to or greater than 0.7 GPa.

In another aspect, a method for creating a clavicle protective devicefor protecting a clavicle of a subject is provided. In one embodiment, amethod for creating a clavicle protective device for protecting aclavicle of a subject may include: creating a digital three-dimensionalsurface model corresponding to at least a portion of a torso of thesubject and a plurality of three-dimensional markers positioned on theat least a portion of the torso; creating a digital three-dimensionalmodel of the clavicle protective device based at least in part on thedigital three-dimensional surface model; and creating the clavicleprotective device based at least in part on the digitalthree-dimensional model. The clavicle protective device may include acontoured member configured to cover at least a portion of the clavicle.The contoured member may include a first contact portion, a secondcontact portion, and a bridge portion positioned between the firstcontact portion and the second contact portion. The first contactportion may be configured to contact the subject's body above theclavicle. The second contact portion may be configured to contact thesubject's body below the clavicle. The bridge portion may be configuredto be spaced apart from the subject's body when the first contactportion and the second contact portion contact the subject's body.

In some embodiments, creating the digital three-dimensional surfacemodel may include capturing a three-dimensional scan of the at least aportion of the torso and the plurality of three-dimensional markers. Insome embodiments, the three-dimensional markers may be positioned alongthe clavicle. In some embodiments, the plurality of three-dimensionalmarkers may include a first three-dimensional marker positioned over anacromioclavicular joint of the subject, a second three-dimensionalmarker positioned over a sternoclavicular joint of the subject; and athird three-dimensional marker positioned over the clavicle at anintermediate location between the acromioclavicular joint and thesternoclavicular joint. In some embodiments, creating the clavicleprotective device may include creating the clavicle protective device byadditive manufacturing.

In still another aspect, a method for creating a digitalthree-dimensional model of a clavicle protective device for protecting aclavicle of a subject is provided. In one embodiment, a method forcreating a digital three-dimensional model of a clavicle protectivedevice for protecting a clavicle of a subject may include: receiving adigital three-dimensional surface model corresponding to at least aportion of a torso of the subject and a plurality of three-dimensionalmarkers positioned on the at least a portion of the torso; and creatinga digital three-dimensional model of the clavicle protective devicebased at least in part on the digital three-dimensional surface model.The clavicle protective device may include a contoured member configuredto cover at least a portion of the clavicle. The contoured member mayinclude a first contact portion, a second contact portion, and a bridgeportion positioned between the first contact portion and the secondcontact portion. The first contact portion may be configured to contactthe subject's body above the clavicle. The second contact portion may beconfigured to contact the subject's body below the clavicle. The bridgeportion may be configured to be spaced apart from the subject's bodywhen the first contact portion and the second contact portion contactthe subject's body.

In some embodiments, the three-dimensional markers may be positionedalong the clavicle. In some embodiments, the plurality ofthree-dimensional markers may include a first three-dimensional markerpositioned over an acromioclavicular joint of the subject, a secondthree-dimensional marker positioned over a sternoclavicular joint of thesubject; and a third three-dimensional marker positioned over theclavicle at an intermediate location between the acromioclavicular jointand the sternoclavicular joint. In some embodiments, creating thedigital three-dimensional model based at least in part on the digitalthree-dimensional surface model may include creating a first sketch lineconnecting a plurality of points corresponding to the plurality ofthree-dimensional markers. In some embodiments, a curvature of thebridge portion may correspond to a curvature of the first sketch line.In some embodiments, creating the digital three-dimensional model basedat least in part on the digital three-dimensional surface model also mayinclude: creating a second sketch line offset from the first sketch lineand extending along the three-dimensional surface model; and creating athird sketch line offset from the first sketch line and extending alongthe three-dimensional surface model. In some embodiments, creating thedigital three-dimensional model based at least in part on the digitalthree-dimensional surface model also may include creating a firstnon-uniform rational basis (NURB)-spline surface connecting the firstsketch line, the second sketch line, and the third sketch line. In someembodiments, a shape of the bridge portion may correspond to a shape ofthe first NURB-spline surface. In some embodiments, creating the digitalthree-dimensional model based at least in part on the digitalthree-dimensional surface model also may include: creating a secondNURB-spline surface extending from the first NURB-spline surface andalong the three-dimensional surface model; and creating a thirdNURB-spline surface extending from the first NURB-spline surface andalong the three-dimensional surface model. In some embodiments, a shapeof the first contact portion may correspond to a shape of the secondNURB-spline surface, and a shape of the second contact portion maycorrespond to a shape of the third NURB-spline surface.

In yet another aspect, a method for creating a digital three-dimensionalmodel of a bone protective device for protecting a bone of a subject isprovided. In one embodiment, a method for creating a digitalthree-dimensional model of a bone protective device for protecting abone of a subject may include: receiving a digital three-dimensionalsurface model corresponding to at least a portion of a body of thesubject and a plurality of three-dimensional markers positioned on theat least a portion of the body; and creating a digital three-dimensionalmodel of the bone protective device based at least in part on thedigital three-dimensional surface model. The bone protective device mayinclude a contoured member configured to cover at least a portion of thebone. The contoured member may include a first contact portion, a secondcontact portion, and a bridge portion positioned between the firstcontact portion and the second contact portion. The first contactportion may be configured to contact the subject's body adjacent thebone. The second contact portion may be configured to contact thesubject's body adjacent the bone. The bridge portion may be configuredto be spaced apart from the subject's body when the first contactportion and the second contact portion contact the subject's body.

In some embodiments, the three-dimensional markers may be positionedalong the bone. In some embodiments, the plurality of three-dimensionalmarkers may include a first three-dimensional marker positioned over afirst end of the bone, a second three-dimensional marker positioned overa second end of the bone; and a third three-dimensional markerpositioned over the bone at an intermediate location between the firstend and the second end. In some embodiments, creating the digitalthree-dimensional model based at least in part on the digitalthree-dimensional surface model may include creating a first sketch lineconnecting a plurality of points corresponding to the plurality ofthree-dimensional markers. In some embodiments, a curvature of thebridge portion may correspond to a curvature of the first sketch line.In some embodiments, creating the digital three-dimensional model basedat least in part on the digital three-dimensional surface model also mayinclude: creating a second sketch line offset from the first sketch lineand extending along the three-dimensional surface model; and creating athird sketch line offset from the first sketch line and extending alongthe three-dimensional surface model. In some embodiments, creating thedigital three-dimensional model based at least in part on the digitalthree-dimensional surface model also may include creating a firstNURB-spline surface connecting the first sketch line, the second sketchline, and the third sketch line. In some embodiments, a shape of thebridge portion may correspond to a shape of the first NURB-splinesurface. In some embodiments, creating the digital three-dimensionalmodel based at least in part on the digital three-dimensional surfacemodel also may include: creating a second NURB-spline surface extendingfrom the first NURB-spline surface and along the three-dimensionalsurface model; and creating a third NURB-spline surface extending fromthe first NURB-spline surface and along the three-dimensional surfacemodel. In some embodiments, a shape of the first contact portion maycorrespond to a shape of the second NURB-spline surface, and a shape ofthe second contact portion may correspond to a shape of the thirdNURB-spline surface.

According to a first aspect, a clavicle protective device for protectinga clavicle of a subject, the clavicle protective device including: A) acontoured member configured to cover at least a portion of a clavicle,wherein the contoured member includes: 1) an outer profile surroundingan inner surface and an outer surface, wherein the outer profile isdefined at least in part from a boundary representation (BRep) solidmodeling process performed on a point cloud of anatomical data collectedfrom a subject's body; 2) the inner surface configured to face theportion of the clavicle and at least partially conforming to theanatomical data, wherein the inner surface is defined at least in partfrom a non-uniform rational basis (NURB)-spline surface modeling processperformed on the point cloud of anatomical data collected from thesubject's body; 3) the outer surface configured to face away from theportion of the clavicle; 4) a first contact portion configured tocontact the subject's body above the clavicle; 5) a second contactportion configured to contact the subject's body below the clavicle; 6)a bridge portion positioned between the first contact portion and thesecond contact portion, wherein the bridge portion: a) is configured tobe offset from the portion of the clavicle when the first contactportion and the second contact portion contact the subject's body; andb) extends from a first location at a first side of the outer profile toa second location at a second side of the outer profile; and c) includesa length in a first direction extending from the first location to thesecond location and a width in a second direction transverse to thefirst direction, and wherein the length is greater than the width; 7) anIzod impact strength of about 70 J/m; and 8) a flexural modulus of about0.5 GPa.

According to a second aspect, the clavicle protective device of thefirst aspect or any other aspect, wherein the first contact portion andthe second contact portion are spaced apart from one another by thebridge portion.

According to a third aspect, the clavicle protective device of the firstaspect or any other aspect, wherein the bridge portion includes achannel extending along the inner surface.

According to a fourth aspect, the clavicle protective device of thethird aspect or any other aspect, wherein at least a portion of thechannel includes a curved profile.

According to a fifth aspect, the clavicle protective device of thefourth aspect or any other aspect, wherein a curvature of the curvedprofile varies along the at least a portion of the channel.

According to a sixth aspect, the clavicle protective device of the thirdaspect or any other aspect, wherein the channel includes a U-shapedprofile.

According to a seventh aspect, the clavicle protective device of thesixth aspect or any other aspect, wherein the bridge portion furtherincludes a ridge extending along the outer surface.

According to an eighth aspect, the clavicle protective device of theseventh aspect or any other aspect, wherein the ridge includes thecurved profile.

According to a ninth aspect, the clavicle protective device of theseventh aspect or any other aspect, wherein the ridge includes theU-shaped profile.

According to a tenth aspect, the clavicle protective device of the firstaspect or any other aspect, wherein the contoured member includes athickness of about 4 mm.

According to an eleventh aspect, the clavicle protective device of thefirst aspect or any other aspect, wherein a magnitude of the offset isbased at least in part on one or more peak points of the point cloud.

According to a twelfth aspect, a clavicle protective device forprotecting a clavicle of a subject, the clavicle protective deviceincluding: A) a contoured member configured to cover at least a portionof a clavicle, wherein the contoured member includes: 1) an outerprofile surrounding an inner surface and an outer surface, wherein theouter profile is defined at least in part from a boundary representation(BRep) solid modeling process performed on a point cloud of anatomicaldata collected from a subject's body; 2) the inner surface configured toface the portion of the clavicle and at least partially conforming tothe anatomical data, wherein the inner surface is defined at least inpart from a non-uniform rational basis (NURB)-spline surface modelingprocess performed on the point cloud of anatomical data collected fromthe subject's body; 3) the outer surface configured to face away fromthe portion of the clavicle; 4) a first contact portion configured tocontact the subject's body above the clavicle; 5) a second contactportion configured to contact the subject's body below the clavicle; 6)a bridge portion positioned between the first contact portion and thesecond contact portion, wherein the bridge portion: a) is configured tobe offset from the portion of the clavicle when the first contactportion and the second contact portion contact the subject's body,wherein a magnitude of the offset is based at least in part on one ormore peak points of the point cloud; b) extends from a first location ata first side of the outer profile to a second location at a second sideof the outer profile; and c) includes a length in a first directionextending from the first location to the second location and a width ina second direction transverse to the first direction, and wherein thelength is greater than the width; 7) a thickness of about 4 mm; 8) anIzod impact strength of about 70 J/m; and 9) a flexural modulus of about0.5 GPa.

According to a thirteenth aspect, the clavicle protective device of thetwelfth aspect or any other aspect, wherein the first contact portionand the second contact portion are spaced apart from one another by thebridge portion.

According to a fourteenth aspect, the clavicle protective device of thetwelfth aspect or any other aspect, wherein the bridge portion includesa channel extending along the inner surface.

According to a fifteenth aspect, the clavicle protective device of thefourteenth aspect or any other aspect, wherein at least a portion of thechannel includes a curved profile.

According to a sixteenth aspect, the clavicle protective device of thefifteenth aspect or any other aspect, wherein a curvature of the curvedprofile varies along the at least a portion of the channel.

According to a seventeenth aspect, the clavicle protective device of thefourteenth aspect or any other aspect, wherein the channel includes aU-shaped profile.

According to an eighteenth aspect, the clavicle protective device of theseventeenth aspect or any other aspect, wherein the bridge portionfurther includes a ridge extending along the outer surface.

According to a nineteenth aspect, the clavicle protective device of theeighteenth aspect or any other aspect, wherein the ridge includes thecurved profile.

According to a twentieth aspect, the clavicle protective device of theeighteenth aspect or any other aspect, wherein the ridge includes theU-shaped profile.

These and other aspects, features, and benefits of the claimed devices,systems, and methods will become apparent from the following detailedwritten description of the preferred embodiments and aspects taken inconjunction with the following drawings, although variations andmodifications thereto may be effected without departing from the spiritand scope of the novel concepts of the disclosure.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings illustrate one or more embodiments and/oraspects of the disclosure and, together with the written description,serve to explain the principles of the disclosure. Wherever possible,the same reference numbers are used throughout the drawings to refer tothe same or like elements of an embodiment, and wherein:

FIG. 1 illustrates an example architecture of a system for creating acustomized protective device for protecting a body portion of a subjectand an example method in accordance with one or more embodiments of thedisclosure;

FIG. 2A is a perspective view of an example clavicle protective devicefor protecting a clavicle of a subject in accordance with one or moreembodiments of the disclosure;

FIG. 2B is a front view of the clavicle protective device of FIG. 2A;

FIG. 2C is a rear view of the clavicle protective device of FIG. 2A;

FIG. 2D is a top view of the clavicle protective device of FIG. 2A;

FIG. 2E is a bottom view of the clavicle protective device of FIG. 2A;

FIG. 2F is a side view of the clavicle protective device of FIG. 2A;

FIG. 2G is a side view of the clavicle protective device of FIG. 2A;

FIG. 3A illustrates an example digital three-dimensional surface modelcreated according to an example method for creating a customizedclavicle protective device for protecting a clavicle of a subject inaccordance with one or more embodiments of the disclosure, with thedigital surface model corresponding to a torso of the subject and aplurality of three-dimensional markers;

FIG. 3B illustrates an example processed digital three-dimensionalsurface model created according to the example method, with theprocessed digital surface model corresponding to a portion of thesubject's body including the clavicle, at least a portion of the neck,and at least a portion of the shoulder;

FIG. 3C illustrates the example processed digital three-dimensionalsurface model and a first sketch line created according to the examplemethod, showing the first sketch line extending along pointscorresponding to the markers;

FIG. 3D illustrates the example processed digital three-dimensionalsurface model, the first sketch line, a second sketch line, and a thirdsketch line created according to the example method, showing the secondsketch line and the third sketch line offset from the first sketch lineand extending along the processed digital surface model;

FIG. 3E illustrates the example processed digital three-dimensionalsurface model and a first non-uniform rational basis (NURB)-splinesurface created according to the example method, showing the firstNURB-spline surface connecting the first, second, and third sketchlines;

FIG. 3F illustrates the example processed digital three-dimensionalsurface model, the first NURB-spline surface, a second NURB-splinesurface, and a third NURB-spline surface created according to theexample method, showing the second NURB-spline surface and the thirdNURB-spline surface extending from the first NURB-spline surface andalong the processed digital surface model;

FIG. 3G illustrates the example processed digital three-dimensionalsurface model and the first, second, and third NURB-spline surfacescreated according to the example method, showing the first, second, andthird NURB-spline surfaces thickened and an outline corresponding to thecustomized clavicle protective device;

FIG. 3H illustrates the example processed digital three-dimensionalsurface model and a digital three-dimensional model of the customizedclavicle protective device created according to the example method,showing the customized clavicle protective device positioned over anintended body portion of the subject;

FIG. 4A is a front view of an example acromioclavicular joint protectivedevice for protecting an acromioclavicular joint of a subject inaccordance with one or more embodiments of the disclosure;

FIG. 4B is a top view of the acromioclavicular joint protective deviceof FIG. 4A;

FIG. 4C is a bottom view of the acromioclavicular joint protectivedevice of FIG. 4A;

FIG. 4D is a side view of the acromioclavicular joint protective deviceof FIG. 4A;

FIG. 5A illustrates an example processed digital three-dimensionalsurface model and NURB-spline surface created according to an examplemethod for creating a customized acromioclavicular joint protectivedevice for protecting an acromioclavicular joint of a subject inaccordance with one or more embodiments of the disclosure, with thedigital three-dimensional surface model corresponding to a portion ofthe subject's body including the acromioclavicular joint, at least aportion of the neck, and at least a portion of the shoulder;

FIG. 5B illustrates the example processed digital three-dimensionalsurface model and a digital model of the customized acromioclavicularjoint protective device created according to the example method, showingthe customized acromioclavicular joint protective device positioned overan intended body portion of the subject;

FIG. 5C illustrates the example processed digital three-dimensionalsurface model and the digital model of the customized acromioclavicularjoint protective device created according to the example method;

FIG. 5D illustrates the example processed digital three-dimensionalsurface model and the digital model of the customized acromioclavicularjoint protective device created according to the example method;

FIG. 6A is a perspective view of an example finger joint protectivedevice for protecting a finger joint of a subject in accordance with oneor more embodiments of the disclosure;

FIG. 6B is a side view of the finger joint protective device of FIG. 6A;

FIG. 6C is a top view of the finger joint protective device of FIG. 6A;

FIG. 7A illustrates an example digital three-dimensional surface modelcreated according to an example method for creating a customized fingerjoint protective device for protecting a finger joint of a subject inaccordance with one or more embodiments of the disclosure, with thedigital three-dimensional surface model corresponding to a portion of ahand of the subject including a finger thereof;

FIG. 7B illustrates an example processed digital three-dimensionalsurface model created according to the example method, with theprocessed digital three-dimensional surface model corresponding to aportion of the finger including the finger joint;

FIG. 7C illustrates the example processed digital three-dimensionalsurface model and a digital model of the customized finger jointprotective device created according to the example method, showing thecustomized finger joint protective device positioned over an intendedportion of the subject's finger;

FIG. 7D illustrates the example processed digital three-dimensionalsurface model and the digital model of the customized finger jointprotective device created according to the example method;

FIG. 8A is a perspective view of an example ankle protective device forprotecting an ankle of a subject in accordance with one or moreembodiments of the disclosure, with the ankle protective deviceincluding a first contoured member and a second contoured member coupledto one another by a pair of hinges;

FIG. 8B is a front view of the ankle protective device of FIG. 8A;

FIG. 9A illustrates an example digital three-dimensional surface modelcreated according to an example method for creating a customized ankleprotective device for protecting an ankle of a subject in accordancewith one or more embodiments of the disclosure, with the digitalthree-dimensional surface model corresponding to a portion of thesubject's body including the ankle, at least a portion of the foot, andat least a portion of the leg;

FIG. 9B illustrates an example processed digital three-dimensionalsurface model and a NURB-spline surface created according to the examplemethod, with the processed digital three-dimensional surface modelcorresponding to the portion of the subject's body, with the NURB-splinesurface corresponding to a first contoured member of the customizedankle protective device.

FIG. 9C illustrates the example processed digital three-dimensionalsurface model and a NURB-spline surface created according to the examplemethod, with the NURB-spline surface corresponding to the firstcontoured member;

FIG. 9D illustrates the example processed digital three-dimensionalsurface model and a digital model of the first contoured member;

FIG. 9E illustrates a NURB-spline surface created according to theexample method, with the NURB-spline surface corresponding to the firstcontoured member;

FIG. 9F illustrates the example processed digital three-dimensionalsurface model and a NURB-spline surface created according to the examplemethod, with the NURB-spline surface corresponding to a second contouredmember of the customized ankle protective device;

FIG. 9G illustrates the example processed digital three-dimensionalsurface model and a NURB-spline surface created according to the examplemethod, with the NURB-spline surface corresponding to the secondcontoured member;

FIG. 9H illustrates the example processed digital three-dimensionalsurface model and a NURB-spline surface created according to the examplemethod, with the NURB-spline surface corresponding to the secondcontoured member;

FIG. 9I illustrates the example processed digital three-dimensionalsurface model and a digital model of the second contoured member createdaccording to the example method;

FIG. 9J illustrates the example processed digital three-dimensionalsurface model and the digital model of the second contoured member;

FIG. 9K illustrates the example processed digital three-dimensionalsurface model and the digital models of the first contoured member andthe second contoured member;

FIG. 9L illustrates the example processed digital three-dimensionalsurface model and the digital models of the first contoured member andthe second contoured member;

FIG. 9M illustrates the example processed digital three-dimensionalsurface model and the digital models of the first contoured member andthe second contoured member;

FIG. 9N illustrates the example processed digital three-dimensionalsurface model and the digital models of the first contoured member andthe second contoured member;

FIG. 9O illustrates the example processed digital three-dimensionalsurface model and the digital models of the first contoured member andthe second contoured member;

FIG. 9P illustrates the example processed digital three-dimensionalsurface model and the digital models of the first contoured member andthe second contoured member;

FIG. 10A is a perspective view of an example forearm protective devicefor protecting a forearm of a subject in accordance with one or moreembodiments of the disclosure;

FIG. 10B is a perspective view of the forearm protective device of FIG.10A;

FIG. 11A illustrates an example digital three-dimensional surface modelcreated according to an example method for creating a customized forearmprotective device for protecting a forearm of a subject in accordancewith one or more embodiments of the disclosure, with the digital surfacemodel corresponding to a portion of an arm of the subject and a glove,including the forearm, and at least a portion of the bicep;

FIG. 11B illustrates an example processed digital three-dimensionalsurface model created according to the example method, with theprocessed digital surface model corresponding to a portion of thesubject's arm including the forearm;

FIG. 11C illustrates a BRep body created using the processed digitalthree-dimensional surface model according to the example method;

FIG. 11D illustrates a digital mesh model created according to theexample method;

FIG. 11E illustrates a processed digital mesh model created according tothe example method;

FIG. 11F illustrates a processed digital mesh model created according tothe example method;

FIG. 11G illustrates a processed digital mesh model created according tothe example method;

FIG. 11H illustrates the digital mesh model and a digital model of theforearm protective device created according to the example method;

FIG. 11I illustrates the digital mesh model and the digital model of theforearm protective device;

FIG. 11J illustrates the digital mesh model and the digital model of theforearm protective device;

FIG. 11K illustrates the digital mesh model and the digital model of theforearm protective device;

FIG. 12A is a perspective view of an example thumb protective device forprotecting a thumb of a subject in accordance with one or moreembodiments of the disclosure;

FIG. 12B is a perspective view of the thumb protective device of FIG.12A;

FIG. 13A illustrates an example digital three-dimensional surface modelcreated according to an example method for creating a customized thumbprotective device for protecting a thumb of a subject in accordance withone or more embodiments of the disclosure, with the digital surfacemodel corresponding to a portion of a hand of the subject, including thethumb;

FIG. 13B illustrates an example processed digital three-dimensionalsurface model created according to the example method, with theprocessed digital surface model corresponding to the portion of thesubject's hand including the thumb;

FIG. 13C illustrates an example processed digital three-dimensional meshmodel and a BRep body created according to the example method;

FIG. 13D illustrates the example processed digital three-dimensionalmesh model and a processed BRep body created according to the examplemethod;

FIG. 13E illustrates the digital mesh model and a digital model of thethumb protective device created according to the example method;

FIG. 13F illustrates the digital mesh model and the digital model of thethumb protective device;

FIG. 13G illustrates the digital mesh model and the digital model of thethumb protective device; and

FIG. 13H illustrates the digital mesh model and the digital model of thethumb protective device.

DETAILED DESCRIPTION

For the purpose of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings and specific language will be used todescribe the same. It will, nevertheless, be understood that nolimitation of the scope of the disclosure is thereby intended; anyalterations and further modifications of the described or illustratedembodiments, and any further applications of the principles of thedisclosure as illustrated therein are contemplated as would normallyoccur to one skilled in the art to which the disclosure relates. Alllimitations of scope should be determined in accordance with and asexpressed in the claims.

Whether a term is capitalized is not considered definitive or limitingof the meaning of a term. As used in this document, a capitalized termshall have the same meaning as an uncapitalized term, unless the contextof the usage specifically indicates that a more restrictive meaning forthe capitalized term is intended. However, the capitalization or lackthereof within the remainder of this document is not intended to benecessarily limiting unless the context clearly indicates that suchlimitation is intended.

Embodiments of customized protective devices for protecting a portion ofa body of a subject (i.e., a person) from injury as well as relatedsystems and methods for creating customized protective devices areprovided. As described herein, a customized protective device may becreated for a particular subject in a manner that optimizes the goals ofproviding protection for the intended body portion, allowing the subjectto maintain a normal range of motion, and avoiding or minimizingdiscomfort caused by wearing the device. The customized protectivedevices described herein generally may include a contoured member thatis configured to cover (i.e., extend over) at least a portion of anintended body portion of the subject, with the contoured member havingan inner surface and an outer surface disposed opposite one another. Theinner surface may be configured to face the intended body portion whenthe customized protective device is worn by the subject, while the outersurface may be configured to face away from the intended body portion.

In some instances, a customized protective device may be configured foruse with respect to an injured or previously injured body portion toprevent or inhibit further injury or re-injury of the body portion andpromote desired hearing. In some embodiments, such a customizedprotective device may be configured to provide direct impact shieldingfor the injured or previously injured body portion. As described indetail below, direct impact shielding may be provided by configuring thecustomized protective device to include one or more contact portions andone or more non-contact portions. When the protective device is worn bythe subject, the contact portion(s) may contact the subject's body,while the non-contact portion(s) may be offset (i.e., spaced apart) fromthe subject's body. In this manner, the non-contact portion(s) may coveran injured or previously injured body portion, while the contactportions distribute impact forces to surrounding body portions. In otherembodiments, as described below, a customized protective device may beconfigured to limit a range of motion of a joint of the subject, forexample, an injured joint, such that the joint is protected from furtherinjury.

In some instances, a customized protective device may be configured foruse with respect to an uninjured body portion to prevent or inhibitinjury of the body portion. For example, such a customized protectivedevice may be configured to cover a body portion that is likely to beimpacted during participation in a given activity, such as contactsports. This type of customized protective device generally may beform-fit to the body portion to be protected, without any non-contactportions. Further, such a customized protective device may be configuredto allow the subject to maintain a normal range of motion of nearbyjoints, while also avoiding undesired contact between the protectivedevice and body portions other than those covered by the device.

Several types of customized protective devices are described herein andillustrated in the accompanying drawings. It will be appreciated thatthese protective devices are merely examples, and that features of thedescribed and illustrated devices, as well as the methods for creatingthe devices, may be applied similarly to other types of customizedprotective devices for protecting other portions of a subject's body.

Referring now to FIG. 1 , a system 100 for creating customizedprotective devices in accordance with one or more embodiments of thedisclosure is depicted. The system 100 may be used for creating theexample protective devices described herein as well as other devices.The system 100 generally may include one or more subject data capturedevice(s) 110, one or more digital modeling device(s) 112, and one ormore additive manufacturing device(s) 114. The system 100 may includeany number of these devices 110, 112, 114. In some embodiments, asshown, the subject data capture device 110, the digital modeling device112, and the additive manufacturing device 114 may be in communicationwith one another via one or more network(s) 102. In this manner, thedevices 110, 112, 114 may exchange data, such as subject data, digitalmodels, or other types of data or information related to creation ofcustomized protective devices, as described herein. In some embodiments,the devices 110, 112, 114 also may be in communication with one or moredata server(s) 116, for example, via the network 102, to send data tothe data server 116 for storage or to retrieve stored data from the datastorage 116. Although the devices 110, 112, 114 and the data server 116are depicted in FIG. 1 as separate devices, in some embodiments, two ormore, or all, of these devices may be implemented as a single device.

The subject data capture device 110 may be configured to capture subjectdata for use in creating a customized protective device for a particularsubject. In some embodiments, subject data includes, but is not limitedto, anatomical data corresponding to spatial dimension and orientationof a subject's body (e.g., or a portion thereof, such as a forearm,torso, clavicle, hand, and etc.). In some embodiments, the subject datacapture device 110 may be or may include a three-dimensional (3D)scanner, and the subject data may be a three-dimensional scan capturedby the scanner. Various types of 3D scanners may be used, such as astructured-light scanner, a time-of-flight laser scanner, atriangulation-based laser scanner, or other suitable scanning device forobtaining a 3D scan. In some embodiments, the 3D scanner may have acapture rate that is equal to or greater than thirty (30) frames persecond. Such a capture rate may be advantageous to avoid challenges inhaving the subject remain still long enough to capture a high-qualityscan. In some embodiments, the 3D scanner may have a range that is equalto or greater than one (1) meter, which may be beneficial in view of aneed to scan large anatomical features in a short time. In someembodiments, the 3D scanner may have an accuracy that is equal to orgreater than five hundred (500) microns, providing the scanner withsuitable precision to accurately represent all anatomical features in adigital manner. In some embodiments, the subject data capture device 110may be or may include a photogrammetry device configured to capture andanalyze photographic images.

The digital modeling device 112 may be configured to process subjectdata received from the subject data capture device 110 and create adigital model of a customized protective device for the intendedsubject. In doing so, the digital modeling device 112 may utilizevarious computer-aided design (CAD) software capabilities. In someembodiments, the subject data received from the subject data capturedevice 110 may be in the form of a point cloud (i.e., a set of datapoints arranged in three-dimensional space), and the digital modelingdevice 112 may transform the point cloud into a triangle mesh (i.e., amesh of interlocking triangular surfaces), although other suitable typesof polygon mesh may be used. The digital modeling device 112 then maymanipulate the mesh into a form that is suitable for the creation of acustomized protective device by processing and editing the mesh. Forexample, the digital modeling device 112 may perform various processingoperations, such as cropping, cutting, merging, extruding, reducing, andfilling. After processing the mesh, the digital modeling device 112 maydigitally create the customized protective device. In other words, thedigital modeling device 112 may create a digital model of the customizedprotective device. In creating the digital model of the customizedprotective device, the digital modeling device 112 may use one or more3D modeling techniques.

In at least one embodiment, a technique includes non-uniform rationalbasis (NURB)-spline surface modeling, which may involve manipulatingsurfaces to create the customized protective device from the processedthree-dimensional surface model for the intended subject. In variousembodiments, a NURB-spline surface may be applied and mapped over theanatomical geometry of the three-dimensional surface model. In someembodiments, as described below, the NURB-spline surface may bemanipulated to account for distribution of loads in view of the intendedpurpose of the protective device.

The NURB-spline surface may be thickened to a thickness required for thespecific protective device application, and then may be trimmed to adesired geometry for the application. This technique advantageously mayallow for substantial design freedom to create complex hinges, bridgefeatures, or other types of structural features. Use of the NURB-splinesurface modeling technique is described further below with respect tocertain example customized protective devices. In some embodiments,NURB-spline surface modeling includes generating and manipulatingT-spline surfaces.

According to one embodiment, a second 3D modeling technique includesboundary representation (BRep) solid modeling, which may create a newsolid body from the processed mesh. In one or more embodiments, the newbody is different from the processed mesh, for example, because theboundaries of the solid body are represented mathematically within thesoftware. In at least one embodiment, complex designs and patterns maybe applied to create a desired shape of the customized protectivedevice. The three-dimensional model for the subject may be brought intoa computer program as a surface, converted and thickened into a body(BRep), and then trimmed down and altered in various ways to form adesired shape for the protective device. As discussed below, the BRepsolid modeling technique may be useful in the creation of differenttypes of customized protective devices.

The additive manufacturing device 114 may be configured to create acustomized protective device using a digital model created by thedigital modeling device 112. In some embodiments, the additivemanufacturing device 114 may be or may include a 3D printer, such as astereolithography (SLA) printer, although other suitable additivemanufacturing techniques may be used. The properties of the materialused to form the customized protective device generally may depend ofthe application and intended purpose of the device. As described below,certain types of protective devices may provide direct impact shieldingform injured or previously injured body portions, for example, bycreating the device with a bridge or dome structure. For such devices,the material used must highly impact resistant and stiff enough toresist deformation. In some embodiments, the material used for thesedevices may have an Izod impact strength that is equal to or greaterthan about 60-100 J/m, about 60-70 J/m, about 70 J/m, about 70-80 J/m,about 80-90 J/m, or about 90-100 J/m. In at least one embodiment, thematerial demonstrates a flexural modulus that is equal to or greaterthan about 0.4-0.9 GPa, about 0.4-0.5 GPa, about 0.5 GPa, about 0.5-0.6GPa, about 0.6-0.7 GPa, about 0.7-0.8 GPa, or about 0.8-0.9 GPa. Othertypes of protective devices may be configured to prevent or inhibitrotation or movement of joints. For such applications, it may beadvantageous to use a material that emphasizes stiffness over impactresistance.

Additionally, the material may be sufficiently tough such that flexingis not likely to cause material failure. In some embodiments, thematerial for devices intended to prevent or inhibit rotation or movementof joints may have a flexural modulus that is equal to or greater than0.85 GPa and an elongation at break of more than 50% in tensile testing.In various embodiments, the material of the protective devices isbiocompatible and resists deformation during exposure to heat up to 150degrees Fahrenheit. In some embodiments, a customized protective devicemay be formed of polypropylene photopolymer, although other suitablematerials satisfying the necessary material properties may be used.

FIG. 1 depicts an example method 120 for creating a customizedprotective device for protecting a portion of a subject's body, as maybe carried out using the system 100 described above. At step 122, themethod 120 may include capturing subject data for a subject. Forexample, the subject data capture device 110 may be used to capture thesubject data for the subject. In some embodiments, the subject datacapture device 110 may be or may include a 3D scanner, which may capturethe subject data in the form of a point cloud. The method 120 also mayinclude, at step 124, creating a digital three-dimensional surface modelcorresponding to at least a portion of the subject's body. The digitalthree-dimensional surface model may be created based at least in part onthe subject data. For example, the digital modeling device 112 may beused to receive the subject data from the subject data capture device110 and create the digital three-dimensional surface model for thesubject using the subject data. Various processing operations may becarried out in view of the intended protective device application. Atstep 126 of the method 120, a digital model of a protective device forthe subject may be created based at least in part on the digitalthree-dimensional surface model. For example, the digital modelingdevice 112 may be used to create the digital model of the protectivedevice based at least in part on the anatomical geometry of the digitalthree-dimensional surface model. Various modeling techniques may beused, as described above. At step 128, the method 120 may includecreating the protective device based at least in part on the digitalmodel. For example, the additive manufacturing device 114 may be used tocreate the protective device from the digital model using one or moreadditive manufacturing techniques. In some embodiments, the additivemanufacturing device 114 may be or may include a 3D printer, which mayform the protective device from a material suitable for the device'sintended configuration and function. It will be appreciated that themethod 120 sets forth the general steps for creating a customizedprotective device. Further details regarding particular exampleprotective devices are provided below.

FIGS. 2A-2G illustrate an example clavicle protective device 200 forprotecting a clavicle (i.e., a collarbone) of a subject in accordancewith one or more embodiments of the disclosure. As shown, the clavicleprotective device 200 may be in the form of a pad or brace configured tocover at least a portion of the subject's clavicle. The clavicleprotective device 200 may be particularly useful for subjects engagingin contact sports after suffering a clavicle fracture, inhibitingre-injury and significant pain to the subject during the healingprocess. Existing methods for protecting the clavicle often restrictmotion and are uncomfortable to wear. The clavicle protective device 200not only addresses these issues but also functions to displace impactaway from the healing clavicle.

As shown, the clavicle protective device 200 may include or be formed asa contoured member 202 that is configured to cover at least a portion ofthe intended subject's clavicle. The contoured member 202 may have aninner surface 204 configured to face the clavicle and an outer surface206 configured to face away from the clavicle. The inner surface 204 canbe configured to substantially, or at least partially, conform toanatomical data collected from the subject's body. In one example, theinner surface 204 is configured based on a point cloud of anatomicaldata that is collected from a scan of a subject's body. In this example,the inner surface 204 is configured to at least partially conform to theanatomical data such the inner surface 205 generally (or substantially)conforms to the subject's body. To provide impact displacement, thecontoured member 202 may include one or more contact portions and one ormore noncontact portions. In some embodiments, as shown, the contouredmember 202 may include a first contact portion 210, a second contactportion 220, and a bridge portion 230. The contact portions 210, 220 maybe configured to contact the subject's body adjacent to, and not on, theclavicle. In this manner, in the event that the clavicle protectivedevice 200 is impacted, the contact portions 210, 220 may not transfersignificant forces to the clavicle. As shown, the first contact portion210 may be configured to contact the subject's body above the clavicle,and the second contact portion 220 may be configured to contact thesubject's body below the clavicle. The bridge portion 230 may bepositioned between the first contact portion 210 and the second contactportion 220 and configured to be spaced apart from the subject's bodywhen the first contact portion 210 and the second contact portion 220contact the subject's body. In other words, when the clavicle protectivedevice 200 is properly positioned on the subject, a gap or spacingexists between the bridge portion 230 and the subject's body. Inparticular, according to the illustrated embodiment, the bridge portion230 may be configured to extend over and be spaced apart from theportion of the clavicle covered by the contoured member 202 when thefirst contact portion 210 and the second contact portion 220 contact thesubject's body. According to one embodiment, the bridge portion 230 isshaped to substantially conform to contours of a clavicle. In oneexample, a clavicle demonstrates a generally “S”-shaped cross-sectionand the bridge portion 230 is shaped to conform to the contours of thecross-section.

As shown, the first contact portion 210 and the second contact portion220 may be spaced apart from one another by the bridge portion 230. Inother words, in some embodiments, the first contact portion 210 and thesecond contact portion 220 do not contact one another. As shown, thecontoured member 202 may have an outer profile (as viewed in FIGS. 2Band 2C) that surrounds each of the inner surface 204 and the outersurface 206. In some embodiments, as illustrated, the bridge portion 230may extend from a first location at a first side of the outer profile toa second location at a second side of the outer profile, with the firstside and the second side being positioned opposite one another. Thebridge portion 230 may have a length in a first direction extending fromthe first location to the second location and a width in a seconddirection transverse to the first direction. In some embodiments, asshown, the length of the bridge portion 230 may be greater than thewidth of the bridge portion 230.

The bridge portion 230 may include a channel 234 extending along theinner surface 204 of the contoured member 202. As shown, the channel 234may have a curved profile along at least a portion of the bridge portion230. In some embodiments, a curvature of the curved profile of thechannel 234 may vary along the at least a portion of the of the bridgeportion 230. For example, the curvature of the curved profile of thechannel 234 may correspond to the curvature of the subject's clavicle.In some embodiments, as shown, the channel 234 may have a U-shapedprofile along at least a portion of the bridge portion 230. The bridgeportion 230 may include a ridge 236 extending along the outer surface206 of the contoured member 202. In some embodiments, the ridge 236 mayhave a curved profile along at least a portion of the bridge portion230. In some embodiments, as shown, the ridge 236 may have a U-shapedprofile along at least a portion of the bridge portion 230. The materialused to form the contoured member 202 may be selected in accordance withthe material properties discussed above (e.g., because the contouredmember 202 may be configured to provide impact displacement). Forexample, the contoured member 202 may be formed of a material having anIzod impact strength that is equal to or greater than about 60-100 J/m,about 60-70 J/m, about 70 J/m, about 70-80 J/m, about 80-90 J/m, orabout 90-100 J/m. In the same example, the material can demonstrate aflexural modulus that is equal to or greater than about 0.4-0.9 GPa,about 0.4-0.5 GPa, about 0.5 GPa, about 0.5-0.6 GPa, about 0.6-0.7 GPa,about 0.7-0.8 GPa, or about 0.8-0.9 GPa. In various embodiments, thecombination of properties provides an advantageous combination of impactresistance and stiffness to enable desired function of the clavicleprotective device 200, particularly for use in contact sports.

With reference to FIGS. 3A-3H, the following method may be used tocreate the clavicle protective device 200. The process may begin withpositioning a plurality of markers on the subject. The markers may bethree-dimensional or two-dimensional markers. In one or moreembodiments, the markers are shaped or textured so as to be readilyvisible in a 3D scan of the subject's body when positioned thereon.Non-limiting examples of two-dimensional markers include, but are notlimited to, adhesives, such as stickers, bodily drawings, and othertwo-dimensional indicia provided at a target site (e.g., a subject'sbody). For the purposes of illustration and discussion, the foregoingdescriptions of device generation processes are placed in the context ofthree-dimensional markers; however, it will be understood by one ofordinary skill in the art that such processes may be performed usingtwo-dimensional markers or a combination of two- and three-dimensionalmarkers.

The markers may be positioned along the clavicle to allow the locationand curvature of the clavicle to be readily determined from the 3D scan.In some embodiments, a first marker may be positioned over theacromioclavicular joint at the lateral end of the bone, and a secondmarker may be positioned over the sternoclavicular joint at the medialend of the bone. One or more additional markers may be positioned overthe clavicle at one or more intermediate locations between the first andsecond markers to facilitate visualization of the curvature of theclavicle along its length in the 3D scan. A 3D scanner may be used todigitally capture a 3D surface model of at least a portion of thesubject's torso. As discussed above, the 3D scanner may generate a pointcloud (e.g., after positioning the markers on the subject's body). Thepoint cloud may be converted into a raw standard tessellation language(.stl) file, as shown in FIG. 3A. In the depicted embodiment, fivemarkers are visible, indicating the position and curvature of theclavicle. The .stl file may be imported into a mesh editing software forprocessing. FIG. 3B shows a cropped 3D surface model, including therelevant anatomy for properly creating the clavicle protective device200. In at least one embodiment, one or more features to be included formodeling the clavicle protective device 200 include, but are not limitedto, the clavicle, the adjacent curvature of the neck, and the entiretyof the adjacent shoulder. During processing of the surface model, allstray surfaces may be deleted, and all holes may be filled to provide acontinuous surface.

FIG. 3C shows the processed mesh as may be imported into softwarecapable of NURB-spline surface modeling. In some embodiments, modelingof the clavicle protective device 200 includes creating a first sketchline that follows the curvature of the clavicle and connects a pluralityof points corresponding to the plurality of markers. As shown in FIG.3C, the sketch line may have a curved line having a curved 3D shape thatfollows the markers and thus the curvature of the clavicle. A secondsketch line and a third sketch line may be created, as shown in FIG. 3D,with the second and third sketch lines each being offset from the firstsketch line. The second sketch line may be offset above the first sketchline and may extend along the surface model, while the third sketch linemay be offset below the first sketch line and may extend along thesurface model. In this manner, the second and third sketch lines may beform-fit to the corresponding anatomy of the surface model, while thefirst sketch line may be fit to the peaks of the markers of the surfacemodel, as shown. According to one embodiment, peak points of a pointcloud (e.g., which may correspond to peaks of markers used in scanning asubject) at least partially define a magnitude by which a bridge portionis offset from a subject's body (e.g., when one or more contact portionsof the protective device contact the subject's body). In someembodiments, the amount of offset of the second and third sketch linesfrom the first sketch line may be determined based on the thickness andanatomy of the subject's clavicle. The three sketch lines may be used tocreate the bridge portion 230 with an appropriate size and curvature forthe subject's clavicle.

After creation of the sketch lines, a first NURB-spline surface may becreated, as illustrated in FIG. 3E. The height of the first NURB-splinesurface may correspond to the heights of the markers, as shown. In thismanner, the first NURB-spline surface may facilitate formation of thebridge portion 230. A second NURB-spline surface and a third NURB-splinesurface then may be created, as shown in FIG. 3F, with the secondNURB-spline surface extending upward from the first NURB-spline surfaceand along the anatomical surface geometry of the model, and the thirdNURB-spline surface extending downward from the first NURB-splinesurface and along the anatomical surface geometry of the model. In thismanner, the second NURB-spline surface and the third NURB-spline surfacemay be form-fit to the surface geometry of the model and thus thecorresponding portions of the subject's body. Accordingly, the secondand third NURB-spline surfaces may be used to create the first andsecond contact portions 210, 220 with an appropriate size and curvaturefor the subject's body. As shown in FIG. 3F, the entirety of theresulting overall NURB-spline surface (the combination of the first,second, and third NURB-spline surfaces) thus may be sized and shaped tocontact the subject's body, except for the arched portion (correspondingto the bridge portion 230) that is raised up over the accurately mappedclavicle. The overall NURB-spline surface can be thickened, convertedfrom a NURB-spline geometry into BRep, and cropped into the final shapeof the intended clavicle protective device 200. In some embodiments, the3D model of the clavicle protective device 200 may be thickened to about1-8 mm, about 1-2 mm, about 2-3 mm, about 3-4 mm, about 4 mm, about 4-5mm, about 5-6 mm, about 6-7 mm, or about 7-8 mm. The shape of theclavicle protective device 200 may be optimized to retain the greatestcoverage of the clavicle while reducing contact points on the neck andshoulder.

FIGS. 4A-4D illustrate an example acromioclavicular joint protectivedevice 400 for protecting an acromioclavicular (AC) joint of a subjectin accordance with one or more embodiments of the disclosure. As shown,the AC protective device 400 may be in the form of a pad or braceconfigured to cover at least a portion of the subject's AC joint. Insome embodiments, as shown, the AC protective device 400 is configuredto cover the entire AC joint. The AC protective device 400 may beparticularly useful for subjects engaging in contact sports afterdislocation of the AC joint, inhibiting re-injury and significant painto the subject during the healing process. Existing methods forprotecting the AC joint often restrict motion, are uncomfortable towear, and slip from the intended positioning during use. The ACprotective device 400 not only addresses these issues but also functionsto displace impact away from the healing AC joint.

As shown, the AC protective device 400 may include or be formed as acontoured member 402 that is configured to cover at least a portion ofthe intended subject's AC joint. The contoured member 402 may have aninner surface 404 configured to face the AC joint and an outer surface406 configured to face away from the AC joint. To provide impactdisplacement, the contoured member 402 may include one or more contactportions and one or more noncontact portions. In some embodiments, asshown, the contoured member 402 may include a contact portion 410 and adome portion 430. The contact portion 410 may be configured to contactthe subject's body adjacent to, and not on, the AC joint. In thismanner, in the event that the AC protective device 400 is impacted, thecontact portion 410 will not transfer forces to the AC joint. As shown,the contact portion 410 may be configured to contact the subject's bodysurrounding the AC joint. The dome portion 430 may be surrounded by thecontact portion 410 and configured to be spaced apart from the subject'sbody when the contact portion 410 contacts the subject's body. In otherwords, when the AC protective device 400 is properly positioned on thesubject, a gap or spacing exists between the dome portion 430 and thesubject's body. In particular, according to the illustrated embodiment,the dome portion 430 may be configured to extend over and be spacedapart from the portion of the AC joint covered by the contoured member402 when the contact portion 410 contacts the subject's body.

As shown, the contact portion 410 may entirely surround the dome portion430. In other words, in some embodiments, the contact portion 410 mayextend entirely around the dome portion 430. The dome portion 430 mayinclude an internal space 434 defined by the inner surface 404 of thecontoured member 402. As shown, the internal space 434 may have a curvedprofile. For example, the curvature of the curved profile of the channel434 may correspond to the curvature of the subject's AC joint. The domeportion 430 also may include a protrusion 436 defined by the outersurface 406 of the contoured member 402. In some embodiments, theprotrusion 436 may have a curved profile. Material used to form thecontoured member 402 may be selected in accordance with the materialproperties discussed above (e.g., because the contoured member 402 isconfigured to provide impact displacement). For example, the contouredmember 402 may be formed of a material having an Izod impact strengththat is equal to or greater than 90 J/m and a flexural modulus that isequal to or greater than 0.7 GPa. This combination of propertiesprovides an advantageous combination of impact resistance and stiffnessto enable desired function of the AC protective device 400, particularlyfor use in contact sports.

With reference to FIGS. 5A-5H, the following method may be used tocreate the AC protective device 400. The process may begin withpositioning a three-dimensional marker on the subject. The marker may beshaped or textured so as to be readily visible in a 3D scan of thesubject's body when positioned thereon. The marker may be positionedover the subject's AC joint to allow the location and curvature of theAC joint to be readily determined from the 3D scan. A 3D scanner may beused (e.g., after positioning the marker on the subject's body) todigitally capture a 3D surface model of at least a portion of thesubject's torso, including the AC joint and at least a portion of thesubject's shoulder. As discussed above, the 3D scanner may generate apoint cloud. The point cloud may be converted into a raw standardtessellation language (.stl) file. FIG. 5A shows a processed 3D surfacemodel, including the relevant anatomy for properly creating the ACprotective device 400. During processing of the surface model, all straysurfaces may be deleted, and all holes may be filled to provide acontinuous surface. FIG. 5A shows the processed mesh as may be importedinto software capable of NURB-spline surface modeling. The modeling ofthe AC protective device 400 may be carried out in a manner similar tothat described above with respect to the clavicle protective device 200.As shown in FIG. 5A, a NURB-spline surface may be created. TheNURB-spline surface may be thickened, converted from a NURB-splinegeometry into BRep, and cropped into the final shape of the intended ACprotective device 400, as shown in FIGS. 5B-5D. In some embodiments, the3D model of the AC protective device 400 may be thickened to aparticular magnitude, such as four (4) mm. The shape of the ACprotective device 400 may be optimized to provide the greatest coverageof the AC joint while reducing contact points on the neck and shoulderthat would restrict motion or cause discomfort.

FIGS. 6A-6D illustrate an example finger joint protective device 600 forprotecting a joint of a finger of a subject, such as the proximalinterphalangeal (PIP) joint, in accordance with one or more embodimentsof the disclosure. As shown, the finger joint protective device 600 maybe in the form of a pad or brace configured to cover at least a portionof the subject's finger joint. In some embodiments, as shown, the fingerjoint protective device 600 is configured to cover the entire fingerjoint. The finger joint protective device 600 may be particularly usefulfor subjects engaging in contact sports after dislocation of the fingerjoint, inhibiting re-injury and significant pain to the subject duringthe healing process. Alternatively, the finger joint protective device600 may be used to prevent dislocation of the finger joint. As shown,the finger joint protective device 600 may include or be formed as acontoured member 602 that is configured to cover at least a portion ofthe intended subject's finger joint. The contoured member 602 may havean inner surface 604 configured to face the finger joint and an outersurface 606 configured to face away from the finger joint. The entiretyof the inner surface 604 may be configured to contact the subject'sfinger and joint. In other words, the contoured member 602 may beconfigured such that the inner surface 604 form-fits to the subject'sanatomy. FIGS. 7A-7D illustrate an example method for creating thefinger joint protective device 600, which may be carried out in a manneras described above for the relevant anatomy.

FIGS. 8A-8D illustrate an example ankle protective device 800 forprotecting an ankle of a subject in accordance with one or moreembodiments of the disclosure. As shown, the ankle protective device 800may be in the form of a brace configured to cover at least a portion ofthe subject's ankle. The ankle protective device 800 may be particularlyuseful for subjects engaging in contact sports after suffering a highankle sprain, inhibiting re-injury and significant pain to the subjectduring the healing process by inhibiting rotation of the ankle. Asshown, the ankle protective device 800 may include a first contouredmember 802 configured to cover at least a portion of the intendedsubject's foot, and a second contoured member 812 configured to cover atleast a portion of the intended subject's leg. The first contouredmember 802 and the second contoured member 812 may be coupled to oneanother by a pair of hinges to allow restricted movement of the ankle.Each contoured member 802, 812 may have an inner surface 804, 814configured to face the subject's anatomy and an outer surface 806, 816configured to face away from the anatomy. Portions or all of the innersurfaces 804, 814 may be configured to contact the adjacent anatomy ofthe subject. In other words, portions or all of the contoured members802, 812 may be configured such that the inner surfaces 804, 814form-fit to the subject's anatomy. FIGS. 9A-9P illustrate an examplemethod for creating the ankle protective device 800, which may becarried out in a manner as described above for the relevant anatomy.

FIGS. 10A-10B illustrate an example forearm protective device 1000 forprotecting a forearm of a subject in accordance with one or moreembodiments of the disclosure. As shown, the forearm protective device1000 may be in the form of a pad or brace configured to cover at least aportion of the subject's forearm. In some embodiments, as shown, theforearm protective device 1000 is configured to cover a majority of theforearm. The forearm protective device 1000 may be particularly usefulfor subjects engaging in contact sports in which the forearm is oftencontacted, such as in lacrosse or hockey. As shown, the forearmprotective device 1000 may include or be formed as a contoured member1002 that is configured to cover at least a portion of the intendedsubject's forearm. The contoured member 1002 may have an inner surface1004 configured to face the forearm and an outer surface 1006 configuredto face away from the forearm. The entirety of the inner surface 1004may be configured to contact the subject's forearm. In other words, thecontoured member 1002 may be configured such that the inner surface 1004form-fits to the subject's anatomy. FIGS. 11A-11K illustrate an examplemethod for creating the forearm protective device 1000, which may becarried out in a manner as described above for the relevant anatomy.

FIGS. 12A-12B illustrate an example thumb protective device 1200 forprotecting a thumb of a subject in accordance with one or moreembodiments of the disclosure. As shown, the thumb protective device1200 may be in the form of a pad or brace or support configured to coverat least a portion of the subject's thumb and hand. In some embodiments,as shown, the thumb protective device 1200 is configured to cover amajority of the thumb. The thumb protective device 1200 may beparticularly useful for subjects engaging in contact sports in which thethumb is often contacted. As shown, the thumb protective device 1200 mayinclude or be formed as a contoured member 1202 that is configured tocover at least a portion of the intended subject's thumb and hand.

The contoured member 1202 may have an inner surface 1204 configured toface the thumb and an outer surface 1206 configured to face away fromthe thumb. The entirety of the inner surface 1204 may be configured tocontact the subject's thumb or hand. In other words, the contouredmember 1202 may be configured such that the inner surface 1204 form-fitsto the subject's anatomy. FIGS. 13A-13H illustrate an example method forcreating the thumb protective device 1200, which may be carried out in amanner as described above for the relevant anatomy.

Although the various protective devices described above may be providedcontoured members formed as solid structures in some embodiments,alternative configurations of the contoured members may be used. Forexample, in some embodiments, the contoured members may be formed as, ormay include, lattice structures having voids. The lattice structure, andthe voids thereof, may in some instances provide force absorption whenthe device is impacted. In this manner, lattice structures may provide agreater degree of protection for the subject (e.g., as compared tonon-lattice-based structures of previous approaches). For example, acontoured member or a portion thereof may have multiple layers includinga solid, form-fitting layer contacting the subject's body, an adjacentlayer formed as a lattice structure that allows energy to be absorbed.In some embodiments, the lattice structure may form the outer surface ofthe contoured member. In other embodiments, an additional solid, outerlayer may be provided over the lattice structure layer. Variousconfigurations of solid structures and lattice structures may be usedfor the devices.

From the foregoing, it will be understood that various aspects of theprocesses described herein are software processes that execute oncomputer systems that form parts of the system. Accordingly, it will beunderstood that various embodiments of the system described herein aregenerally implemented as specially-configured computers includingvarious computer hardware components and, in many cases, significantadditional features as compared to conventional or known computers,processes, or the like, as discussed in greater detail herein.Embodiments within the scope of the present disclosure also includecomputer-readable media for carrying or having computer-executableinstructions or data structures stored thereon. Such computer-readablemedia can be any available media which can be accessed by a computer, ordownloadable through communication networks. By way of example, and notlimitation, such computer-readable media can comprise various forms ofdata storage devices or media such as RAM, ROM, flash memory, EEPROM,CD-ROM, DVD, or other optical disk storage, magnetic disk storage, solidstate drives (SSDs) or other data storage devices, any type of removablenon-volatile memories such as secure digital (SD), flash memory, memorystick, etc., or any other medium which can be used to carry or storecomputer program code in the form of computer-executable instructions ordata structures and which can be accessed by a general purpose computer,special purpose computer, specially-configured computer, mobile device,etc.

When information is transferred or provided over a network or anothercommunications connection (either hardwired, wireless, or a combinationof hardwired or wireless) to a computer, the computer properly views theconnection as a computer-readable medium. Thus, any such connection isproperly termed and considered a computer-readable medium. Combinationsof the above should also be included within the scope ofcomputer-readable media. Computer-executable instructions comprise, forexample, instructions and data which cause a general purpose computer,special purpose computer, or special purpose processing device such as amobile device processor to perform one specific function or a group offunctions.

Those skilled in the art will understand the features and aspects of asuitable computing environment in which aspects of the disclosure may beimplemented. Although not required, some of the embodiments of theclaimed systems may be described in the context of computer-executableinstructions, such as program modules or engines, as described earlier,being executed by computers in networked environments. Such programmodules are often reflected and illustrated by flow charts, sequencediagrams, exemplary screen displays, and other techniques used by thoseskilled in the art to communicate how to make and use such computerprogram modules. Generally, program modules include routines, programs,functions, objects, components, data structures, application programminginterface (API) calls to other computers whether local or remote, etc.that perform particular tasks or implement particular defined datatypes, within the computer. Computer-executable instructions, associateddata structures and/or schemas, and program modules represent examplesof the program code for executing steps of the methods disclosed herein.The particular sequence of such executable instructions or associateddata structures represent examples of corresponding acts forimplementing the functions described in such steps.

Those skilled in the art will also appreciate that the claimed and/ordescribed systems and methods may be practiced in network computingenvironments with many types of computer system configurations,including personal computers, smartphones, tablets, hand-held devices,multi-processor systems, microprocessor-based or programmable consumerelectronics, networked PCs, minicomputers, mainframe computers, and thelike. Embodiments of the claimed system are practiced in distributedcomputing environments where tasks are performed by local and remoteprocessing devices that are linked (either by hardwired links, wirelesslinks, or by a combination of hardwired or wireless links) through acommunications network. In a distributed computing environment, programmodules may be located in both local and remote memory storage devices.

An exemplary system for implementing various aspects of the describedoperations, which is not illustrated, includes a computing deviceincluding a processing unit, a system memory, and a system bus thatcouples various system components including the system memory to theprocessing unit. The computer will typically include one or more datastorage devices for reading data from and writing data to. The datastorage devices provide nonvolatile storage of computer-executableinstructions, data structures, program modules, and other data for thecomputer.

Computer program code that implements the functionality described hereintypically comprises one or more program modules that may be stored on adata storage device. This program code, as is known to those skilled inthe art, usually includes an operating system, one or more applicationprograms, other program modules, and program data. A user may entercommands and information into the computer through keyboard, touchscreen, pointing device, a script containing computer program codewritten in a scripting language or other input devices (not shown), suchas a microphone, etc. These and other input devices are often connectedto the processing unit through known electrical, optical, or wirelessconnections.

The computer that effects many aspects of the described processes willtypically operate in a networked environment using logical connectionsto one or more remote computers or data sources, which are describedfurther below. Remote computers may be another personal computer, aserver, a router, a network PC, a peer device or other common networknode, and typically include many or all of the elements described aboverelative to the main computer system in which the systems are embodied.The logical connections between computers include a local area network(LAN), a wide area network (WAN), virtual networks (WAN or LAN), andwireless LANs (WLAN) that are presented here by way of example and notlimitation. Such networking environments are commonplace in office-wideor enterprise-wide computer networks, intranets, and the Internet.

When used in a LAN or WLAN networking environment, a computer systemimplementing aspects of the system is connected to the local networkthrough a network interface or adapter. When used in a WAN or WLANnetworking environment, the computer may include a modem, a wirelesslink, or other mechanisms for establishing communications over the widearea network, such as the Internet. In a networked environment, programmodules depicted relative to the computer, or portions thereof, may bestored in a remote data storage device. It will be appreciated that thenetwork connections described or shown are exemplary and othermechanisms of establishing communications over wide area networks or theInternet may be used.

While various aspects have been described in the context of a preferredembodiment, additional aspects, features, and methodologies of theclaimed systems will be readily discernible from the description herein,by those of ordinary skill in the art. Many embodiments and adaptationsof the disclosure and claimed systems other than those herein described,as well as many variations, modifications, and equivalent arrangementsand methodologies, will be apparent from or reasonably suggested by thedisclosure and the foregoing description thereof, without departing fromthe substance or scope of the claims. Furthermore, any sequence(s)and/or temporal order of steps of various processes described andclaimed herein are those considered to be the best mode contemplated forcarrying out the claimed systems. It should also be understood that,although steps of various processes may be shown and described as beingin a preferred sequence or temporal order, the steps of any suchprocesses are not limited to being carried out in any particularsequence or order, absent a specific indication of such to achieve aparticular intended result. In most cases, the steps of such processesmay be carried out in a variety of different sequences and orders, whilestill falling within the scope of the claimed systems. In addition, somesteps may be carried out simultaneously, contemporaneously, or insynchronization with other steps.

Aspects, features, and benefits of the claimed devices and methods forusing the same will become apparent from the information disclosed inthe exhibits and the other applications as incorporated by reference.Variations and modifications to the disclosed systems and methods may beeffected without departing from the spirit and scope of the novelconcepts of the disclosure.

It will, nevertheless, be understood that no limitation of the scope ofthe disclosure is intended by the information disclosed in the exhibitsor the applications incorporated by reference; any alterations andfurther modifications of the described or illustrated embodiments, andany further applications of the principles of the disclosure asillustrated therein are contemplated as would normally occur to oneskilled in the art to which the disclosure relates.

The foregoing description of the exemplary embodiments has beenpresented only for the purposes of illustration and description and isnot intended to be exhaustive or to limit the devices and methods forusing the same to the precise forms disclosed. Many modifications andvariations are possible in light of the above teaching.

The embodiments were chosen and described in order to explain theprinciples of the devices and methods for using the same and theirpractical application so as to enable others skilled in the art toutilize the devices and methods for using the same and variousembodiments and with various modifications as are suited to theparticular use contemplated. Alternative embodiments will becomeapparent to those skilled in the art to which the present devices andmethods for using the same pertain without departing from their spiritand scope. Accordingly, the scope of the present devices and methods forusing the same is defined by the appended claims rather than theforegoing description and the exemplary embodiments described therein.

What is claimed is:
 1. A clavicle protective device for protecting a clavicle of a subject, the clavicle protective device comprising: a contoured member configured to cover at least a portion of a clavicle, wherein the contoured member comprises: an outer profile surrounding an inner surface and an outer surface, wherein the outer profile is defined at least in part from a boundary representation (BRep) solid modeling process performed on a point cloud of anatomical data collected from a subject's body; the inner surface configured to face the portion of the clavicle and at least partially conforming to the anatomical data, wherein the inner surface is defined at least in part from a non-uniform rational basis (NURB)-spline surface modeling process performed on the point cloud of anatomical data collected from the subject's body; the outer surface configured to face away from the portion of the clavicle; a first contact portion configured to contact the subject's body above the clavicle; a second contact portion configured to contact the subject's body below the clavicle; a bridge portion positioned between the first contact portion and the second contact portion, wherein the bridge portion: is configured to be offset from the portion of the clavicle when the first contact portion and the second contact portion contact the subject's body; extends from a first location at a first side of the outer profile to a second location at a second side of the outer profile; and comprises a length in a first direction extending from the first location to the second location and a width in a second direction transverse to the first direction, and wherein the length is greater than the width; an Izod impact strength of about 600-100 J/m; and a flexural modulus of 0.4-0.9 GPa.
 2. The clavicle protective device of claim 1, wherein the first contact portion and the second contact portion are spaced apart from one another by the bridge portion.
 3. The clavicle protective device of claim 1, wherein the bridge portion comprises a channel extending along the inner surface.
 4. The clavicle protective device of claim 3, wherein at least a portion of the channel comprises a curved profile.
 5. The clavicle protective device of claim 4, wherein a curvature of the curved profile varies along the at least a portion of the channel.
 6. The clavicle protective device of claim 3, wherein the channel comprises a U-shaped profile.
 7. The clavicle protective device of claim 6, wherein the bridge portion further comprises a ridge extending along the outer surface.
 8. The clavicle protective device of claim 7, wherein the ridge comprises the curved profile.
 9. The clavicle protective device of claim 7, wherein the ridge comprises the U-shaped profile.
 10. The clavicle protective device of claim 1, wherein the contoured member comprises a thickness of about 4 mm.
 11. The clavicle protective device of claim 1, wherein a magnitude of the offset is based at least in part on one or more peak points of the point cloud.
 12. A clavicle protective device for protecting a clavicle of a subject, the clavicle protective device comprising: a contoured member configured to cover at least a portion of a clavicle, wherein the contoured member comprises: an outer profile surrounding an inner surface and an outer surface, wherein the outer profile is defined at least in part from a boundary representation (BRep) solid modeling process performed on a point cloud of anatomical data collected from a subject's body; the inner surface configured to face the portion of the clavicle and at least partially conforming to the anatomical data, wherein the inner surface is defined at least in part from a non-uniform rational basis (NURB)-spline surface modeling process performed on the point cloud of anatomical data collected from the subject's body; the outer surface configured to face away from the portion of the clavicle; a first contact portion configured to contact the subject's body above the clavicle; a second contact portion configured to contact the subject's body below the clavicle; a bridge portion positioned between the first contact portion and the second contact portion, wherein the bridge portion: is configured to be offset from the portion of the clavicle when the first contact portion and the second contact portion contact the subject's body, wherein a magnitude of the offset is based at least in part on one or more peak points of the point cloud; and extends from a first location at a first side of the outer profile to a second location at a second side of the outer profile; and comprises a length in a first direction extending from the first location to the second location and a width in a second direction transverse to the first direction, and wherein the length is greater than the width; a thickness of 4 mm; an Izod impact strength of 60-100 J/m; and a flexural modulus of about 0.4-0.9 GPa.
 13. The clavicle protective device of claim 12, wherein the first contact portion and the second contact portion are spaced apart from one another by the bridge portion.
 14. The clavicle protective device of claim 12, wherein the bridge portion comprises a channel extending along the inner surface.
 15. The clavicle protective device of claim 14, wherein at least a portion of the channel comprises a curved profile.
 16. The clavicle protective device of claim 15, wherein a curvature of the curved profile varies along the at least a portion of the channel.
 17. The clavicle protective device of claim 14, wherein the channel comprises a U-shaped profile.
 18. The clavicle protective device of claim 17, wherein the bridge portion further comprises a ridge extending along the outer surface.
 19. The clavicle protective device of claim 18, wherein the ridge comprises the curved profile.
 20. The clavicle protective device of claim 18, wherein the ridge comprises the U-shaped profile. 